NCT00816309

Brief Summary

Bronchiectasis is a chronic chest condition which causes a persistent cough and frequent chest infections. One of the main forms of treatment is chest physiotherapy. Physiotherapy is thought to improve cough and help clear the airways of sticky sputum. Traditionally, physiotherapy techniques can be awkward, but recently a new device (a simple mouthpiece, called the Acapella device) has been developed to make physiotherapy practise easier. This study aims to assess how helpful regular physiotherapy using a new mouthpiece is in patients with severe bronchiectasis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

April 1, 2011

Status Verified

July 1, 2010

Enrollment Period

1.2 years

First QC Date

December 31, 2008

Last Update Submit

March 31, 2011

Conditions

Bronchiectasis

Keywords

physiotherapybronchiectasis

Outcome Measures

Primary Outcomes (1)

  • 24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire)

    3 months

Secondary Outcomes (1)

  • spirometry (FEV1, FVC, FEF 25-75), incremental shuttle test, St George's Respiratory Questionnaire and Nottingham Health Profile NHP-2, quantitative bacteriology.

    3 months

Study Arms (2)

Acapella Physiotherapy

EXPERIMENTAL

Physiotherapy with acapella versus no physiotherapy

Device: Acapella Physiotherapy

No physiotherapy

NO INTERVENTION

Physiotherapy with acapella versus no physiotherapy

Interventions

Acapella PhysiotherapyDEVICE

twice daily- around 20 minutes

Acapella Physiotherapy

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate and Severe Bronchiectasis
  • No regular chest physiotherapy

You may not qualify if:

  • Moderate or Severe COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16 4SA, United Kingdom

Location

Related Publications (1)

  • Murray MP, Pentland JL, Hill AT. A randomised crossover trial of chest physiotherapy in non-cystic fibrosis bronchiectasis. Eur Respir J. 2009 Nov;34(5):1086-92. doi: 10.1183/09031936.00055509. Epub 2009 Jun 18.

    PMID: 19541717DERIVED

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Officials

  • Adam T Hill, MBChB MD

    NHS Lothian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 31, 2008

First Posted

January 1, 2009

Study Start

October 1, 2007

Primary Completion

December 1, 2008

Study Completion

March 1, 2009

Last Updated

April 1, 2011

Record last verified: 2010-07

Locations

GB(1)